Overview
Sponsor-declared trial summary
coronary artery disease Aortic valve disease Mitral valve disease Tricuspidal valve disease or combination of the above
The main study objective is to evaluate the respiratory effects of oxycodone PCA using measurement and analysis of patients’ peripheral oxygen saturation (SpO2), possible desaturations and their duration and respiratory rate. The connection of these changes to use of oxycodone PCA, i.e. amount of drug used, plasma con…
Key facts
- Sponsor
- Pohjois-Savon hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 23 Mar 2025 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Oxycodone analysis will be financed with grants from cardiac surgery unit
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy, Safety
The main study objective is to evaluate the respiratory effects of oxycodone PCA using measurement and analysis of patients’ peripheral oxygen saturation (SpO2), possible desaturations and their duration and respiratory rate. The connection of these changes to use of oxycodone PCA, i.e. amount of drug used, plasma concentrations of oxycodone and its metabolites are evaluated.
Secondary objectives 4
- 1. Does the observed desaturations influence mortality 30 days, 6 weeks, 3, 6 and 12 months after heart surgery?
- 2. Does the possible observed desaturations influence morbidity 30 days, 6 weeks, 3, 6 and 12 months after heart surgery? a) Post-operative arrhythmias b) myocardial infarction c) cerebral circulation disorders D) peripheral arterial occlusions e) infections f) prolonged pain g) ability to function and return to activities of everyday life
- 3. Effect of psychological factors on possible pain chronification; how anxiety, depression, resilience affect recovery, pain prolongation and health-related quality of life after heart surgery
- 4. Do patients feel that they benefit from the performed heart surgery
Conditions and MedDRA coding
coronary artery disease Aortic valve disease Mitral valve disease Tricuspidal valve disease or combination of the above
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011078 | Coronary artery disease | 100000004849 |
| 20.0 | PT | 10061589 | Aortic valve disease | 100000004849 |
| 20.0 | LLT | 10013138 | Diseases of tricuspid valve | 10007541 |
| 20.0 | LLT | 10013126 | Diseases of mitral valve | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Age > 18 years • Patient has indication for open heart surgery using cardiopulmonary bypass with conventional extracorporeal perfusion or miniperfusion method. • The patient understands the study protocol • The patient gives informed consent
Exclusion criteria 1
- • Age < 18 years • BMI over 35 kg/m2 • Sensitivity to used drugs or their excipients. • Hepatic (MELD-score 15 or over) or renal insufficiency (GFR less than 30 mL/min) • Difficult respiratory disease (FEV1 less than 1,2 L) or need of supplementary oxygen • Any severity of recognized sleep apnoea (need of nasal CPAP) or disease of central nervous respiratory centre • No informed consent • Other reason, the researcher evaluates that patient is not eligible for the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Nightly pulse oximetry desaturations: amount, depth, and time of recovery heir duration and respiratory rate. The connection of these changes to use of oxycodone PCA use.
Secondary endpoints 4
- Pain after cardiac surgery, morbidity, anxiety and depression, resilience, life satisfaction and heath related quality of life
- Pain assessment daily with NRS at the hospital
- Surgical complications with Clavien-Dindo classification
- Pain outside hospital with Brief Pain Inventory (BPI)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Oxanest® 10 mg/ml injektionsvätska, lösning
PRD2787309 · Product
- Active substance
- Oxycodone Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA05 — OXYCODONE
- Marketing authorisation
- 6646
- MA holder
- TAKEDA OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Panadol Forte 1000 mg tabletti, kalvopäällysteinen
PRD300785 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 21 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 11963
- MA holder
- HALEON DENMARK APS
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pohjois-Savon hyvinvointialue
- Sponsor organisation
- Pohjois-Savon hyvinvointialue
- Address
- Puijonlaaksontie 2, P. O. Box 1711 P. O. Box 1711
- City
- Kuopio
- Postcode
- 70211
- Country
- Finland
Scientific contact point
- Organisation
- Pohjois-Savon hyvinvointialue
- Contact name
- Merja Kokki
Public contact point
- Organisation
- Pohjois-Savon hyvinvointialue
- Contact name
- Merja Kokki
Sponsor responsibilities
- Article 77 compliance
- Pohjois-Savon hyvinvointialue
- Contact point sponsor
- Pohjois-Savon hyvinvointialue
- Article 77 implementation
- Pohjois-Savon hyvinvointialue
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 100 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2025-03-23 | 2025-03-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | HKo_Sydanuni Trial protocol_26_8_2024 valmis | 2 |
| Protocol (for publication) | SYdanunisignedMkokki | 1 |
| Recruitment arrangements (for publication) | recruitment sydanuni | 1 |
| Subject information and informed consent form (for publication) | tiedote ja lupa sydanuni | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | oxanest SmPC-2 | 1 |
| Synopsis of the protocol (for publication) | synopsis sydanuni | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Finland | Acceptable 2024-09-27
|
2024-09-27 |